跳至主要内容
临床试验/NCT04103385
NCT04103385已完成不适用

Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military

Miami University2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
2
主要终点
Multidimensional Assessment of Interoceptive Awareness

研究概览

简要总结

Background: Interoception is defined as the "sense of the physiological condition of the entire body" and is crucial for recognizing emotions and sensations (e.g., hunger, temperature, pain) and responding accordingly. The investigator's lab has conducted several independent studies and two pilot studies that support the hypothesis that disrupted interoception leads one to be disconnected from the body, and thus more able to harm the body should one desire to do so. Research suggests that interoceptive deficits may not only differentiate those who are thinking about suicide from those who engage in suicidal behavior, but it may also provide information about who is at imminent risk for suicidal behavior. The identification of novel, short-term risk factors, like interoceptive deficits, allows for the development of new treatment applications for suicide, which is important for several reasons: 1) suicide rates have increased in recent years, especially among military populations, and 2) existing treatment approaches are often ineffective, lengthy, expensive, or impractical for large-scale dissemination. This project evaluates a novel, brief intervention for interoceptive deficits and suicidal behavior with the potential to be acceptable and feasible for a military population.

详细描述

Background: Interoception is defined as the "sense of the physiological condition of the entire body" and is crucial for recognizing emotions and sensations (e.g., hunger, temperature, pain) and responding accordingly. The investigator's lab has conducted several independent studies and two pilot studies that support the hypothesis that disrupted interoception leads one to be disconnected from the body, and thus more able to harm the body should one desire to do so. Research suggests that interoceptive deficits may not only differentiate those who are thinking about suicide from those who engage in suicidal behavior, but it may also provide information about who is at imminent risk for suicidal behavior. The identification of novel, short-term risk factors, like interoceptive deficits, allows for the development of new treatment applications for suicide, which is important for several reasons: 1) suicide rates have increased in recent years, especially among military populations, and 2) existing treatment approaches are often ineffective, lengthy, expensive, or impractical for large-scale dissemination. This project evaluates a novel, brief intervention for interoceptive deficits and suicidal behavior with the potential to be acceptable and feasible for a military population.

Specific Aims and Hypotheses:

Aim 1: Determine whether the interoception training procedure (Reconnecting to Internal Sensations and Experiences [RISE]) decreases interoceptive deficits, suicidal ideation compared to a control condition. H1: Participants receiving the interoceptive training will demonstrate decreased interoceptive deficits relative to controls and relative to their pre-training levels.

H2: Participants receiving the interoceptive training will demonstrate decreased suicidal ideation relative to controls and relative to their pre-training levels.

H3: Group differences between the interoceptive training and control conditions will be maintained at one- and three-month follow-ups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

We will attempt to mask care provider. The Investigators will be completely blind to condition assignment. Outcomes will be assessed via computer and thus will also be masked.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Being seen for behavioral health services at Wright-Patterson Medical Center (WPMC) or Madigan Army Medical Center (MAMC) for participants recruited at those sites only; other participants were recruited through online advertisement
  • •Active Duty Service Members (MAMC & WPMC) and Veterans (online arm)
  • •Between the ages of 18-65
  • •English language fluency

排除标准

  • •Active psychosis or mania,
  • •Serious suicidal intent requiring hospitalization or immediate treatment.

研究组 & 干预措施

Restoring Individual Strength and Energy

Active Comparator

Aims to reduce life stressors and improve physical health

干预措施: RISE (Reconnecting to Individual Strength and Energy) (Behavioral)

Reconnecting to Internal Sensations and Experiences

Experimental

Aims to improve "interoception" or connection to the body's emotions & internal sensation and reduce suicidal ideation.

干预措施: RISE (Reconnecting to Internal Sensations and Experiences) (Behavioral)

结局指标

主要结局

Multidimensional Assessment of Interoceptive Awareness

时间窗: Within one week of completing the intervention. Also administered at one and three month follow-up.

This 35-item scale has 8 subscales that measure the ability to recognize and accurately identify emotions and physiological sensations.

次要结局

  • Suicidal ideation(Within one week of completing the intervention. Also administered at one and three month follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

April Smith

Assistant Professor

Auburn University

研究点 (2)

Loading locations...

相似试验